EUROPEAN COMMISSION APPROVES BLINCYTO® IN PHILADELPHIA CHROMOSOME-NEGATIVE CD19-POSITIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA IN THE CONSOLIDATION PHASE

BLINCYTO Added to Multiphase Consolidation Chemotherapy Significantly Reduced the Risk of Death Versus Chemotherapy Alone

THOUSAND OAKS, Calif., Jan. 29, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has approved BLINCYTO^® (blinatumomab) monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL).

"This approval represents a significant advancement, offering patients the opportunity to receive BLINCYTO earlier in their treatment pathway, with the potential to improve outcomes," said Jean-Charles Soria, senior vice president of Global Oncology Development at Amgen. "The E1910 data that served as the basis of this approval adds to the growing body of evidence of the meaningful survival impact of BLINCYTO."

The Phase 3 E1910 clinical trial led by ECOG-ACRIN Cancer Research Group studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses. Study results demonstrated that BLINCYTO added to multiphase consolidation chemotherapy showed superior overall survival (OS) versus chemotherapy alone. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO plus chemotherapy arm (n=112) and 62.5% in the chemotherapy arm (n=112).

"While there has been some treatment progress, many patients with newly diagnosed Philadelphia chromosome-negative B-ALL remain at high risk of relapse," said Robin Foà, M.D., emeritus professor of hematology, Sapienza University of Rome. "The E1910 study results highlight that BLINCYTO has the potential to advance frontline consolidation treatment, including patients who are minimal residual disease (MRD)-negative, offering a crucial new option to achieve deeper remissions and improve long-term survival."

The E1910 study was designed and conducted independently from industry. ECOG-ACRIN led the trial with public funding and sponsorship provided by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Other NCI-funded network groups took part in the study. In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement.

About Acute Lymphoblastic Leukemia (ALL)
ALL, also known as acute lymphoblastic leukemia, is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen and central nervous system. In Europe, ALL has an estimated prevalence of 1.28 persons per 100,000 people.¹ Among both children and adults, the most common subtype of ALL is B-ALL.¹ B-ALL begins in immature cells that would normally develop into B-cell lymphocytes, which are white blood cells that grow in bone marrow.^2,3 B-ALL is the most common type of ALL, constituting approximately 75% of cases in adults.⁴

About BLINCYTO^® (blinatumomab)
BLINCYTO is the first globally approved Bispecific T-cell Engager (BiTE^®) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE^® molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE^® immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.

In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of:

• Adults with Philadelphia chromosome-negative CD19-positive relapsed or refractory B-ALL. Patients with Philadelphia chromosome-positive B-ALL should have failed treatment with at least two tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.
• Adults with Philadelphia chromosome-negative CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1%.
• Pediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19-positive B-ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
• Pediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19-positive B-ALL as part of the consolidation therapy.
• Adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive B-ALL as part of consolidation therapy.

BLINCYTO was granted breakthrough therapy and Priority Review designations by the U.S. FDA and is approved in the U.S. for the treatment of:

• Adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-ALL during the consolidation phase of multiphase therapy.
• CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1% in adults and pediatric patients one month or older.
• Relapsed or refractory CD19-positive B-ALL in adults and pediatric patients one month or older.

EU SAFETY INFORMATION FOR BLINCYTO^®
The safety profile of BLINCYTO in the Phase 3 E1910 study was consistent with the known safety profile for BLINCYTO.

See BLINCYTO^® full Summary of Product Characteristics (SmPC) at www.ema.europa.eu

About BiTE^® Technology
Bispecific T-cell Engager (BiTE^®) technology is a targeted immuno-oncology platform that is designed to engage patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE^® immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE^® platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing multiple BiTE^® molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE^® technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE^® technology, visit https://www.amgenoncology.com/bite-platform.html.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. 

In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average^®, and it is also part of the Nasdaq-100 Index^®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube and Threads.

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CONTACT: Amgen, Thousand Oaks
Elissa Snook, 609-251-1407 (media)
Justin Claeys, 805-313-9775 (investors) 

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